Clinical trial

Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Laparoscopic Surgery

Name

04-2022-200028

Description

In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective laparoscopic surgeries.

Trial arms

Trial start

2023-03-20

Estimated PCD

2024-02-20

Trial end

2024-12-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

MgSO4

The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.

Arms:

Cis-Atracurium/MgSO4, Rocuronium/MgSO4

Other names:

Magnesium Sulfate

Rocuronium Bromide

Rocuronium will be administered for intubation at a dose of 0.45-0.6 mg/kg IV and Maintenance at a dose of 0.1-0.2 mg/kg IV on fixed interval

Arms:

Rocuronium/MgSO4

Other names:

Esmeron

Cis-Atracurium

Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.

Arms:

Cis-Atracurium/MgSO4

Other names:

Nimbex

Size

Primary endpoint

The time of no response to nerve stimulation (seconds)

Intraoperative

Eligibility criteria

Inclusion Criteria: 1. Age group 2-12 years old 2. Both genders 3. Children who will be scheduled to undergo elective laparoscopic surgeries. 4. Patients with American Society of Anesthesiologist physical status classification of 1 or 2- Exclusion Criteria: 1. Patients who are beyond the selected age group. 2. Patients on medications that interfered with muscle activity. 3. Allergy to medications used in this study. 4. Neuro-muscular diseases. 5. Renal or hepatic impairment. 6. Hypermagnesemia (\>2.5 mmol) or hypomagnesemia (\<1.7 mmol). 7. Parental refusal to participate in the study

Protocol

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Updated at

2023-02-23

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product